Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Interventions
- Registration Number
- NCT05529784
- Brief Summary
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a sino-nasal chronic inflammatory disease that strongly affects patients' quality of life, especially in difficult-to-treat cases. In severe uncontrolled CRSwNP, the inflammation is mostly driven by a type 2 inflammatory pathway and its management has been rapidly changing during the last 2 years due to Dupilumab approval. It is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit IL-4 and IL-13 signaling.
So far, randomized clinical trials have assessed efficacy and safety of Dupilumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series.
Herewith, the investigators present a multicenter, observational nationwide retrospective real-life study with the aim to confirm the effectiveness and the safety of Dupilumab over the first year of treatment in a real life setting.
The primary objective is to evaluate the volumetric reduction of polyps by measuring the variation of total Nasal Polyp Endoscopic Score (NPS).
The secondary objectives are:
* the evaluation of changes in nasal symptoms, olfactory function and nasal obstruction
* the assessment of the patients' quality of life
* the recording of major and minor complications
* the evaluation of the response to the therapy, according to EPOS2020 criteria and EUFOREA2021
* the assessment of efficacy based on concomitant disease (Asthma and ASA triad)
* the evaluation of potential predictors of clinical response to the therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- confirmed diagnosis of diffuse CRSwNP by endoscopy and CT scan performed at least 6 months prior of the therapy;
- severe disease stage defined by NPS ≥5 or SNOT-22 ≥50;
- inadequate symptom control with INCS therapy;
- failure or intolerance of previous medical treatments (at least 2 cycles of systemic corticosteroid in the last year), and/or failure of previous surgical treatment through nasal endoscopic surgery (ESS), with postoperative complications or no clinical benefit
- pregnant women;
- immunosuppressive therapy;
- patients undergoing radio-chemotherapy treatments for cancer in the 12 months before the starting of therapy;
- concomitant long-term corticosteroid therapy for chronic autoimmune disorders
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Severe, uncontrolled CRSwNP patients in therapy with Dupilumab Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] -
- Primary Outcome Measures
Name Time Method Nasal Polyp Score (NPS) 12 months Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition
- Secondary Outcome Measures
Name Time Method Nasal Polyp Score (NPS) 24 months Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition
Nasal congestion score (NCS) 12 months and 24 months Nasal congestion. Range 0-3. Higher score describes a worse condition
Sinonasal outcome test (SNOT-22) 12 months and 24 months Symptoms. Range 0-110. Higher score describes a worse condition
Sniffin' sticks identification test 12 months and 24 months Olfaction. Range 0-16. Higher score describes a better condition
Visual Analog Scale (VAS) for nasal congestion 12 months and 24 months Nasal congestion. Range 0-10. Higher score describes a more severe symptom
Visual Analog Scale (VAS) for olfaction loss 12 months and 24 months Olfaction loss. Range 0-10. Higher score describes a more severe symptom
Visual Analog Scale (VAS) for craniofacial pain 12 months and 24 months Craniofacial pain. Range 0-10. Higher score describes a more severe symptom
Visual Analog Scale (VAS) for sleeping disorders 12 months and 24 months Sleeping disorders. Range 0-10. Higher score describes a more severe symptom
Need for surgery 12 months and 24 months Number of surgeries performed during therapy
Intranasal corticosteroid adherence 12 months and 24 months Number of days of suspension of intranasal corticosteroids
Need for rescue oral corticosteroids 12 months and 24 months Number of short cycles of oral corticosteroids during therapy
Visual Analog Scale (VAS) for rhinorrhea 12 months and 24 months Rhinorrhea. Range 0-10. Higher score describes a more severe symptom
Visual Analog Scale (VAS) for quality of life 12 months and 24 months Quality of life. Range 0-10. Higher score describes a worse quality of life
Trial Locations
- Locations (19)
ASST Santi Paolo e Carlo - Presidio San Paolo
🇮🇹Milan, Italy
Azienda Ospedaliero-Universitaria di Modena
🇮🇹Modena, Italy
Ospedale maggiore di Novara
🇮🇹Novara, Italy
Fondazione Policlinico Universitario A.Gemelli IRCCS
🇮🇹Roma, Italy
Università La Sapienza
🇮🇹Roma, Italy
AUSL Latina
🇮🇹Latina, Italy
IRCCS San Raffaele
🇮🇹Milano, Italy
AUSL Bologna
🇮🇹Bologna, Italy
Azienda Ospedaliero-Universitaria Policlinico S. Marco
🇮🇹Catania, Italy
Ospedale S.Luigi Gonzaga, Università di Torino
🇮🇹Orbassano, Italy
Azienda Ospedaliero-Universitaria di Padova
🇮🇹Padova, Italy
Policlinico San Matteo-Università di Pavia
🇮🇹Pavia, Italy
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
Azienda USL - IRCCS di Reggio Emilia
🇮🇹Reggio Emilia, Italy
ASL Roma 5
🇮🇹Roma, Italy
A.O.R.N. Ospedali dei Colli
🇮🇹Napoli, Italy
IRCCS CÃ Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera Policlinico Federico II
🇮🇹Napoli, Italy
Azienda Ospedaliero-Universitaria di Sassari
🇮🇹Sassari, Italy